Nanosphere CEO Discusses Q3 2010 Results - Earnings Call Transcript

| About: Nanosphere, Inc. (NSPH)

Nanosphere (NASDAQ:NSPH)

Q3 2010 Earnings Call

November 3, 2010 5:00 p.m. ET


William P. Moffitt III - Chief Executive Officer

J. Roger Moody Jr. – Chief Financial Officer

Michael K. McGarrity - Chief Marketing Officer


Bill Quirk - Piper Jaffray

Scott Gleason - Stephens

Kelly - Jefferies & Co.


Good day, ladies and gentlemen, and welcome to the Third Quarter 2010 Nanosphere Incorporated Earnings Conference Call. [Operator Instructions.]

As a reminder this conference is being recorded for replay purposes. Before this call begins, Nanosphere would like to state that certain statements made during this conference call, which are not based on historical fact, may be deemed to constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Because these forward-looking statements involve known and unknown risks and uncertainties, there are important factors that could cause actual results, events or developments to differ materially from those expressed or implied by these forward-looking statements.

Such factors include those described from time to time in Nanosphere's filings with the United States Securities and Exchange Commission. Please note that Nanosphere undertakes no duty to update this information.

I would now like turn the presentation over to your host for today’s conference, Mr. Bill Moffitt, CEO. You may proceed.

Bill Moffitt

Thank you, operator. Good afternoon everyone and thanks for joining us for Nanosphere’s investor conference call covering the third quarter of 2010. In a few moments I’ll turn the call over to Roger Moody, Chief Financial Officer, and Mike McGarrity, Chief Marketing Officer. But first let me give you my perspective on our progress toward near term milestones that will drive growth over the next several quarters.

We continue to make significant progress towards expending our test menu and the markets we serve. Our goal is to build a global molecular diagnostics company by creating customer and shareholder value through menu expansion and the greater functionality and applicability of our Verigene system.

To achieve our goal, we're focused on addressing three primary market needs. One, enabling the conversion of microbiology to molecular methods, where century-old test methods result in lengthy delays to appropriate therapy, increasing patient risk and the cost of care. Two, providing point of care pharmacogenetic solutions ensuring that the right drug gets to the right patient in the right dose when and where the patient is seen. And three, enabling an earlier detection of this disease through ultra-sensitive protein assays.

Now let me spend a few moments on the progress we're making in each of these key areas. Hospital-based microbiology labs have already begun the conversion to molecular methods. As we have seen historically with virology, single-target assays have been the norm, as underlying technologies are limited in ability to perform complex, broad panels, a limitation we do not have with our nanoparticle-based micro-array platform.

Hospitals need simple, cost-effective systems that can answer broad diagnostic questions by identifying any number of suspected infectious agents. The Verigene SP and our pipeline of infectious disease assays directly address this need.

The first example is our respiratory assay that was cleared on the Verigene SP in the fourth quarter of last year. Since then, we've added subtyping for influenza A. This test includes influenza A, influenza B, RSV A&B, and subtyping for seasonal H1, seasonal H3, and the 2009 novel H1N1, or Swine Flu as it became known.

We have submitted this test to the FDA for 510(k) clearance, and upon clearance we are prepared to commence product shipment to the market this flu season. We expect this new respiratory assay will be the only panel to include all of these targets in a single test and run on a sample-to-result platform.

With continued focus on hospital-acquired infections and the need to quickly identify the underlying bacterial cause of sepsis, there is increasing demand for a broad panel of blood-borne pathogens on a molecular platform that can provide rapid turnaround time, cutting definitive diagnosis and selection of appropriate antibiotic therapy from days to hours. We remain on track to initiate clinical trials for the gram-positive panel near the end of this year. This panel will be followed by gram-negative and fungal panels.

Our microbiology development efforts also include C. difficile and other enteric bacteria assays. The C. difficile test we plan to develop includes both the genetic test to detect the presence of C. difficile and toxin B, a protein test that indicates whether the virus is active.

C. difficile is a bacterium that can cause symptoms ranging from diarrhea to life-threatening inflammation of the colon. We have demonstrated feasibility of running the genomic and protein assays in combination on the same sample, and will move on to full-scale development of this assay in 2011.

Beyond the C. difficile assay, we plan to develop an enteric bacteria panel to detect and identify pathogens that most often result from food poisoning. This panel tests for a wide spectrum of bacteria that are treated with various antibiotics and other antibacterial drug therapies.

We are confident that this comprehensive pipeline of molecular based tests addresses the breadth of test panels, ease of use, and rapid turnaround needs facing the microbiologist today.

Turning for a moment to the area of human and pharmacogenetics, we are also making significant progress. In the third quarter we filed a PMA with the FDA for our 2C19 assay used to guide antiplatelet therapy using clopidogrel, more commonly known by the brand name Plavix. Since filing the clopidogrel PMA application in the third quarter, we've received confirmation from the FDA that they have granted expedited review status.

Expedited review was provided based on the FDA's effort to reduce adverse cardiovascular events in patients who poorly metabolize clopidogrel and because there is no legally marketed diagnostic device currently available. Let me caution you, however, that as a PMA we must complete a rigorous manufacturing site inspection, and while expedited review has been granted, we have no way of predicting the timing of, or certainty that, this test will be approved.

In addition to these efforts, we're in the process of securing CE mark for this 2C19 Plavix metabolism assay, our Warfarin test, and respiratory virus test with subtyping so that we may enter the market in Europe in the first quarter of 2011. In Europe, the demand for pharmacogenetic testing is further developed than in the U.S. CE mark and the recent settlement of our patent dispute with Eppendorf clear the way for us to launch in Europe. Mike McGarrity will share with you more about our plans for international expansion in a few moments.

Following our CE mark clinical trials, we'll begin 510(k) clinical trials to gain FDA clearance on the Verigene SP for assays we originally developed on the Verigene 1. These trials will begin with our hypercoagulation test that continues to drive most of the volume among our initial customer base.

Before turning the call over to Mike, let me provide an update on our efforts in the area of ultrasensitive proteins. You may recall that our plan is to submit a new 510(k) application for our ultrasensitive troponin assay using a different predicate device.

As a reminder, our original submission was based upon the Beckman AcuTnI assay and the potential for inconsistency as noted in Beckman's regulatory filings complicated our data and results analysis. We are near completion of the migration process of this assay to the Verigene SP.

Moving the assay to the Verigene SP will allow our customers to co-locate cardiac troponin testing and the 2C19 assay for clopidogrel metabolism utilizing one common instrument platform. A number of customers have indicated a desire to run the 2C19 assay at the point of care. We also anticipate customers wanting to run the troponin assay in the stat lab that supports the emergency department.

At the same time, our fast-track clinical trial will reach conclusion of the follow up phase at the end of the year. We plan to use the fast-track samples to run the clinical trials in support of our new 510(k) submission and believe we can commence these trials early in 2011.

We've also developed an assay for the ultrasensitive detection of prostate-specific antigen, or PSA. Currently running as a research use-only test, initial studies show that it has great potential for identifying recurrence of prostate cancer much sooner than the existing PSA tests.

More recently, we've worked with a company that believes it has a PSA test method that is much more specific for prostate cancer, and could be used to improve the specificity of initial screening tests. This test could greatly reduce the number of false positives that are sent on for biopsy. But their test requires higher sensitivity than the existing commercial PSA tests. Early testing of this assay, using Verigene technology, indicates that there is great potential for this assay in the prostate cancer screening market, a market far larger than the market for recurrent disease testing. We are still in the early phases of this opportunity, but remain optimistic that the value we see in this test will be validated by future studies.

Now let me turn the call over to Mike McGarrity, who will provide an update on our commercialization programs. Mike?

Mike McGarrity

Thanks Bill. While our placement rate remains relatively unchanged pending regulatory approvals, the commercial organization continues to build a pipeline of target customers awaiting our menu expansion in both infectious disease and pharmacogenetics. We have a number of respiratory customers from last year that validated on our first gen assay, some of which will convert to our subtyping assay when cleared. There are also new pipeline customers awaiting the fastest and only comprehensive panel in a sample-to-result format.

While there are a number of variables, including timing of product clearance and prevalence of flu this season, we are confident that we will add to our customer base and see increased utilization as we make the turn into the new year. It is also important to note that the majority of our respiratory targets are also interested in our bloodstream infection and other microbiology panels in development, serving as a basis for increased utilization as our menu expands.

Similarly, our pharmacogenetic value proposition is gathering support through the developing understanding of drug selection and dosing catalyzed by the black box label to clopidogrel for post-PCI platelet inhibition. We participated in a symposium at the recent transcatheter therapies meeting in which key opinion leaders from both the U.S. and Europe presented a three-pronged update to the clinical need for, and viability of, testing for this critical aspect of interventional outcomes.

First was a presentation of the significant body of data associated with the genetic effects on metabolism of clopidogrel and the associated increase in adverse events. Second was a discussion of treatment protocols related to alternate therapies now approved and available to clinicians. And third was a discussion of the need for on-demand test to provide accurate, timely, and clinically actionable results in the acute setting.

This underscores the as-yet undelivered answer for how to incorporate this testing into PCI protocols. The Verigene system was highlighted in this forum as the only viable option pending regulatory approval. In parallel, the Verigene system was selected for the first prospective study designed to validate point of care testing and associated direct therapy for PCI patients.

While our public comments have been largely focused on the U.S. market, we are very excited to commence our market efforts in both Europe and Asia-Pacific. In Europe there is considerable interest in both our Warfarin and clopidogrel metabolism assays, where we see an advanced understanding of these drug pathways and the associated need for on-demand testing.

We have identified distributors through a comprehensive selection process targeted to customer- and content-focused partners with proven expertise and track records in sales, marketing, and technical support. Pending CE mark, we will launch by country and plan to bring up 3-4 countries per quarter throughout 2011, selling into all of the largest markets by year end. In Asia-Pacific, we have partners identified to guide us through the pre-market and regulatory process for both clopidogrel metabolism and respiratory testing, paving the way for the launch later in 2011.

As we make the turn into 2011, we look forward to advancing our install base and utilization through an expanded menu in both U.S. and international markets.

Now let me turn the call over to Roger, who will review our financial results. Roger?

J. Roger Moody Jr.

Thank you Mike. This afternoon I'll review Nanosphere's third quarter 2010 financial results that are accompanied by today's news release and 10-Q filing, both of which are available on our website, which I invite you to visit at

In the third quarter we made significant progress toward expanding our test menu, settled our dispute with Eppendorf, and completed the pay down of our outstanding debt obligations. These events clear the path for us to focus on new product launches and international expansion.

Now let me review the third quarter financial results. Revenue from product sales was $300,000, and was up slightly compared to third quarter 2009 and second quarter 2010. Third quarter product revenue was predominantly driven by cartridge sales.

Additionally, revenue from grants and contracts was reduced from $400,000 in the third quarter of 2009 to almost zero in 2010, as the assay development projects have been completed and transitioned to the implementation stage.

Total third quarter 2010 revenue was $400,000 as compared to $700,000 in third quarter of 2009. Costs and operating expenses in the third quarter were $11.3 million as compared to $8.7 million in the prior year. The $2.6 million year-over-year increase was driven by the following four factors.

First, we incurred $1.2 million in litigation expenses associated with the Eppendorf matter, which is now settled. This resolution eliminates future uncertainty on this matter and expands our intellectual property portfolio.

Second, we have taken a $700,000 non-cash inventory reserve taken for the Verigene 1 instrument and parts. This reserve is a result of our plan to market our troponin assay on the Verigene SP once we complete the new 510(k) trials and receive regulatory clearance. We also plan to secure regulatory clearance for the tests previously cleared on the Verigene 1 for use on the Verigene SP, thus reducing future demand for Verigene 1 instruments and parts.

Third, we incurred at $500,000 increase in non-cash share-based compensation. And finally, clinical trial expenses associated with our 2C19 and respiratory assays increased by $200,000.

Cash used in operations was $10.1 million. Debt repayment was $1.3 million, and investment activity was $800,000, totaling $12.2 million in cash used during the third quarter of 2010. Please note that our debt facility was fully repaid in August.

Operating cash flows include $3.5 million of the $4 million settlement with Eppendorf, and investing activities included the remaining $500,000 that was recorded as an intangible asset based on the patent's fair value.

In order to give you a sense of our current spending rate, excluding the Eppendorf matter and debt repayment, operating cash used in the third quarter was about $7 million. Cash as of September 30, 2010 was $45.6 million. As previously reported, we continue to project tour cash reserves will fund operations into the middle of 2012.

Summing up, we continue to focus our investments on product expansion and have moved beyond cash drains associated with patent litigation and debt burden. Moving forward, we plan to maintain our investment in product expansion and will adjust investments and sales, service, and manufacturing ramp up commensurate with demand.

Now let me turn the call back over to Bill.

William P. Moffitt III

Thank you Roger. Before moving on to take your questions, let me summarize our key points this afternoon. With product clearances and approvals pending for a broad-panel respiratory virus assay that includes subtyping, and the 2C19 metabolism assay for Plavix, and preparations being made to launch in Europe and Japan in 2011, we are well-positioned to generate growth and accelerate customer placements and market penetration.

Completion of the fast-track clinical trial for our cardiac troponin assay will provide the samples and data we need to resubmit a 510(k) to the FDA for our cardiac troponin assay, which will now be run on the Verigene SP to enable customers to conduct both this assay and the Plavix metabolism test at the point of care.

Our pipeline of new products is designed to meet critical needs in the market and to sustain our growth as we work to build a global leadership position in molecular diagnostics. As we generate customer value, our business will grow and our shareholder value will increase. We're excited about our prospects for the future and appreciate your interest and support for our company.

Now we'd be happy to take your questions, and I'll turn the call back over to the operator.

Question-and-Answer Session


[Operator Instructions.] Your first question comes from the line of Bill Quirk of Piper Jaffray. You may proceed.

Bill Quirk - Piper Jaffray

First question, Bill, just to be clear on the troponin pathway, it sounds like there's obviously multiple parts to submission. So one is that we're going to have the fast tracked data that effectively shows outcomes, and secondly you're in turn going to use those samples and effectively do what we tend to think of more consistent with other 510(k) studies, which is to show correlation between yourself and the buyer instrument.

William P. Moffitt III

That's right. The rigor of the protocols, the IRBs that were used to conduct the fast track trial, is significant. So this is a pivotal clinical trial. It was registered on This is a trial that has been run by an external steering committee of principal investigators. And that has created for us what I guess I would refer to as a "pristine" set of samples, along with follow up on these patients anywhere from 30 days to a full year, every patient having been followed for a full year with intermediate followups along the way.

This gives us an opportunity to run a set of clinical trials to support a 510(k) submission without concern for the viability of the samples, the viability of the population of the patient base those samples came from, or any concerns like that. And then we will run it, since it is a 510(k) it needs to be run against a predicate, and we'll run it against the Bayer-Siemens Troponin Ultra I believe it's called.

Bill Quirk

And then just a follow up to that. Can you help us think a little bit about the timing of the publication of the fast track data? Is it something that you're looking at that you would actually put a press release out? Or rather should we look for this to be presented at an upcoming clinical meeting?

William P. Moffitt III

First of all, let me comment on how we're going to manage to do both the 510(k) and the pivotal trial, if you will, off this same sample set. We are actually going to keep all of the patient data, totally blinded, in the hands of the data analysis company that runs the data set for the pivotal trial. We'll run the samples, do all the comparison work, for the 510(k), and then ultimately use that data both to do the submission and for our principal investigators to do publications. I would expect to see that data presented as reasonably fast as possible following the conclusion of the original running of those samples by the outside CRO that we contract with to run for the pivotal trial. If I had to guess at a timeframe for you I'd guess somewhere in the back half of 2011.

Bill Quirk

And then secondly, if we think about the pipeline outside of troponin, it continues to be fairly robust. How should we think about prioritization should we need to go down that pathway? Do you prioritize the U.S. business first, and potentially Europe and Asia those are less important to the company? How should we think about that strategy?

William P. Moffitt III

I would think about it this way. First of all, as you know we have parallel efforts underway, both in the area of microbiology for the flu test, as well as for the bloodstream infection. We also have work going on on the troponin, and work going on for our blood stream infection assay which at least the gram-positive panel goes into trials about the end of this year. And so we tend to think of these more as parallel efforts, not one really prioritized over the other.

And then with respect to the markets themselves, we tend to think about launching in the U.S., launching in Europe or Asia-Pacific, as soon as we can with respect to the various regulatory requirements in those countries. So for example, when we get 510(k) clearance, or in the case of 2C19 we'll get a PMA approval, we will launch these products. We are ready to go launching the flu assay as soon as we get a clearance there for example.

We are also working to get the CE mark work done on Warfarin, on 2C19, and on the flu assay, and those will be done right about the end of this year, paving the way for that launch in Europe. We have people on the ground in Europe, employees of the company, who have been there now for some time doing the necessary preparatory work and we've just added a resource there to help with launch and to help with customer training and follow up and so forth.

With respect to Asia-Pacific, we have some distributors there that are helping us. We will actually put the flu product in the market in Asia-Pacific in the second half of 2011 and we'll put it in there as a research use only device in order to gather the data necessary to make the submission to MHW in Japan. So we tend to think of the product development efforts as parallel and we think about the market launch effort as only gated by availability of the product and the regulatory hurdles. I hope that helps.


[Operator Instructions.] Your next question comes from the line of Scott Gleason of Stephens. You may proceed.

Scott Gleason - Stephens

When we look at the ultrasensitive PSA test, it was interesting to hear your comments on potentially using that test as a screen modality. I think the issue in the past that you have brought up there is that in ultrasensitive tests it maybe doesn't necessarily differentiate well between background levels of PSA in the blood. Can you talk about what you see in terms of your scientific work that made you change that viewpoint?

William P. Moffitt III

Absolutely, and let me just caution everybody that this is early work. But here's what we've seen so far. First of all, you're absolutely correct that in times past when we've talked about this PSA assay, we've basically said that you don't need an ultrasensitive PSA assay for the initial screening test, because a man with a prostate gland has got a lot of circulating PSA in the bloodstream. But our ultrasensitive assay is extremely useful in detecting recurrent disease after prostatectomy.

In theory, PSA levels should drop to zero. In practice, they drop to undetectable on today's assays, and that's where the ultrasensitive assay is really good at, monitoring patients for recurrent disease after prostatectomy. Because as you've probably heard me say before, we've never seen a patient we couldn't measure PSA on, and that's because of the supersensitive nature of the assay. We can follow that patient all the way post-prostatectomy as the PSA drops down to extraordinarily low levels, and then begin to watch to see whether or not over the course of 30, 60, 90, 180 days it begins to rise again, indicative of recurrent disease. Or it doesn't, indicative of the "good news, they got it all."

And so we've never thought about this ultrasensitive assay as a screening tool for the broader markets, simply because you didn't need that sensitivity. Well, there's another company, and I have to leave their name out of this because we've got a confidentiality agreement with them that doesn't permit us to disclose who they are, that has developed a technology that they believe segments out different bound states of PSA, and that the segmentation of those different bound states of PSA in the blood are directly related to the types of cells that the PSA emanates from.

So a cancer cell, for example, might produce a PSA molecule that has a greater affinity for a certain bound state in the bloodstream. And so their work led them to look at whether or not their assay could actually be a better screening tool. Now what do I mean by better? PSA, the assays that are out there today, you can think of them as like 98% to 100% sensitive. If you've got cancer, your PSA is going to be elevated, and they're going to detect an elevated PSA.

The problem with the assays out there today is they're only about - and it depends on who you read - 35%, 45% specific, meaning that even though you have an elevated PSA you still the majority of the time plus don't have cancer. You have another problem. So that's the bad rap that PSA tests have taken in terms of a screening tool for cancer. It's just not very specific.

What these folks at this other company believe is that by looking at these different bound states, and looking at the ratios of these bound states and other data, that you can actually produce a test that has much greater specificity with respect to cancer.

They put their technology to work, they took a traditional instrument that's in the marketplace with a PSA assay on it. They used it. They ran all their samples, and about half to two-thirds of the time they could not detect anything.

That brought them to us looking for a more sensitive assay, and in fact we ran all their samples - a poster was presented at a urology meeting here not too long ago by some folks from Cleveland Clinic and a couple of other places who did this work - took a look at it and found that with 220 some odd subjects in there the sensitivity of our assay with their technology was 100%. If you had cancer, we found it.

The specificity of the assay went from let's call it 40% for today's assays, to 83%, meaning that you've only now got about 15%, 16%, 17% false positives. So people who are needlessly sent for biopsy. This is early data, but it's another example of where ultrasensitivity really, really matters. And as it turns out, may have significant applicability for the broader PSA screening market and in fact may do what we have hoped our sensitivity would do all along, which is improve the medical utility of current biomarkers, just like we hope to do with the troponin assay.

Scott Gleason

And on the subject of partnerships, I think some people have speculated that with the recent move by the FDA to crack down on laboratory-developed tests that you could see pharma to some extent change their loyalties from wanting to partnership with labs more to wanting to partner with FDA-approved devices, especially ones with capabilities to do multiplex testing. Have you seen any interest in terms of companies wanting to partner on the pharmacogenetic side with some of the recent commentary coming out of the FDA?

William P. Moffitt III

We've definitely seen an increase in the last year or so in general. Pharmaceutical companies wanting to partner on things, and the Eli Lilly relationship that we have, which led to the 2C19 assay and another assay we can't disclose yet as a companion diagnostic, that's certainly an example of that. We've also continued to have a lot of discussions with other pharmaceutical companies. But I would say that we shouldn't think of them as broad-based partnerships. We should think of them as project-based. So a research team inside a pharmaceutical company working on a drug has a need for a test or two or something like that. But we've certainly seen an increase in that kind of activity.

Scott Gleason

And then Bill just last question. We're getting closer to the flu season here. Can you maybe give us a little bit of a sense for how many hospital accounts will be using the new assay on the Verigene SP and what that maybe could look like from a revenue standpoint if we see a normalized flu season?

William P. Moffitt III

I'm going to let Mike answer that.

Mike McGarrity

Scott, we don't provide projections from a revenue standpoint or number of customer placements, but I would tell you that our pipeline has built nicely for the respiratory subtype assay and I think there are a number of factors you've cited and I commented on earlier as far as there is some uncertainty based on prevalence and timing this season because the comparables from last year are odd historically with an early, very high prevalence and then almost a really steep fall off. So I think the biggest thing we're looking at right now is when do we start to see prevalence and based on the timing of that that will probably drive the range of placements, and we'll have a better update for you the next time we get together.


Your next question comes from the line of Bruce Cranna of Jefferies. You may proceed.

Kelly - Jefferies & Co.

This is actually Kelly in for Bruce this afternoon. Thank you for taking the call. Just first, as it relates to the flu question earlier, your customers that are out there now that used the flu test in the past, do you think that there's a lot of inventory out in the field at the moment? Or do you think that this new test will really absolve what's out there and customers will be attracted to the new test once it's approved and commercialized?

Mike McGarrity

There's no stocked up inventory out in the field. Last year the customers' placements that we brought up, validated, and some of them went live and started to use the test. And then with the precipitous fall off that I referred to earlier they just worked through their inventory. So we don't have stock out in the field. We have customers that are bringing up, preparing to validate, and will begin to order for utilization as soon as we are cleared through the FDA.

Kelly - Jefferies & Co.

And then was that submitted to FDA recently? I know you said fourth quarter. Are we looking at early October?

William P. Moffitt III

It was submitted a week or so ago.

Kelly - Jefferies & Co.

And I think I missed this earlier. You talked about the migration studies for the CS test, Warfarin, hypercoag. When was the timing for that?

William P. Moffitt III

We're going to start them in 2011. We're going to finish off the CE marks first, so CE mark on Warfarin and 2C19 and flu, and then we'll get started with the transfer from the migration studies with the hypercoag assay first. And I'd be guessing at timing right now, because I'm not quite sure how long it's going to take us to finish all the CE work. This is really a question on the CE work of some additional clinical work outside. Not a lot. But a lot of documentation and documentation of software, validation of software, etc.

So it's just a lot of work to get done. We should finish the CE work on most of those tests right about the end of the year, first of next year. I think you could look to see us get started with the migration studies for hypercoag on to the Verigene SP sometime mid to late first quarter. Transfer in the European market will already be done by definition with the CE marking.

Kelly - Jefferies & Co.

And then I know you don't give guidance, but looking toward 2011 the operating costs, what do you think is reasonable, what kind of uptick to the R&D given all these clinical trials ongoing?

Roger Moody Jr.

I wouldn't expect a significant uptick in R&D because we are fairly well-funded to cover all of these initiatives and projects that Bill just described. So I wouldn't expect to see an R&D uptick. I would say that for the time being we would expect things to be essentially flat with the exception of the falloff of the debt repayment cash utilization as well as the legal expenses we were incurring in the Eppendorf matter.

In terms of growth of scale up of sales force and manufacturing scale up, we would expect that to start ramping back up again but commensurate with demand. So probably not in the first quarter, first half, because we've already prepared for that volume. But as we start to get into the year and see what the flu season is like and begin to get some of these product clearances, that's when we're going to take a hard look at what we'll do with spend going forward after that.


This concludes the question and answer section of the call. I would now like to turn the call back over to Mr. Bill Moffitt for closing remarks.

William P. Moffitt III

Thank you operator. Thank you everyone for joining us today, and we look forward to keeping in touch with you as we progress and develop and as we reach these significant catalysts that will fuel our future growth. Thanks again everyone and have a good evening.

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Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to All other use is prohibited.


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